Cleared Traditional

Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 (K221857) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221857 · Zhejiang Lude Technology Development Co., Ltd. · Cardiovascular device
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Oct 2022
Decision
108d
Days
Class 2
Risk

K221857 is an FDA 510(k) clearance for the Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, Q.... Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Zhejiang Lude Technology Development Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on October 13, 2022 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhejiang Lude Technology Development Co., Ltd. devices

Submission Details

510(k) Number K221857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2022
Decision Date October 13, 2022
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXQ Blood Pressure Cuff

All 59
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K221857.
ONE-CUF
K230145 · Ge Medical Systems Information Technologies, Inc. · Mar 2023
Aneroid Sphygmomanometer
K222652 · Cardicare Company, Ltd. · Nov 2022
Disposable Blood Pressure Cuff
K222420 · Wenzhou Xikang Medical Instruments Co., Ltd. · Nov 2022
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203
K212416 · Wenzhou Xikang Medical Instruments Co., Ltd. · May 2022
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
K211084 · Shanghai Caremate Medical Device Co., Ltd. · Oct 2021
Reusable NIBP Cuff
K211747 · Shenzhen Coreray Technology Co., Ltd. · Sep 2021